Kenex Radiation Shield installed with GE Healthcare Interventional, Surgery, CT and X-Ray Imaging systems.
Medical device recall Z-1441-2015. Published in FDA’s Enforcement Report on Apr 22, 2015.
No Watch here, and no alerts: openFDA asks that its enforcement data “should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall” (openFDA). For FDA’s own recall emails, subscribe at FDA. FDA’s own record is on accessdata.fda.gov.
The short answer
Published in FDA’s Enforcement Report on Apr 22, 2015. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Terminated its status, in FDA’s file
- 2 states named in where it went
- 797 (3 US, 794 OUS). how much, in FDA’s words
Every line below is in FDA’s own words, with its source beside it. FDA’s terms are explained in FDA’s own words.
How serious is it, by FDA’s class?
Class II, the middle of FDA’s three classes.
“Products that might cause a temporary health problem, or pose only a slight threat of a serious nature. Example: a drug that is under-strength but that is not used to treat life-threatening situations.”
openFDA, in plain words, its enforcement report fields.
“Class II is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.”
FDA’s rule, 21 CFR 7.3(m)(2), eCFR.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
What’s wrong with it?
GE Healthcare has recently become aware of an improper installation of a ceiling suspended pendent supporting a radiation shield and/or surgical lamp. The pendent system was not installed per specified installation requirements. There has been a reported incident of a radiation shield falling from the ceiling causing a minor injury.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
Kenex Radiation Shield installed with GE Healthcare Interventional, Surgery, CT and X-Ray Imaging systems.
797 (3 US, 794 OUS)., in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Mfg Lot or Serial # System ID 00000466434WK8 617340LC 00000495821WK1 916734XR 0000HXNN000113 714229INNOVA 00000582921BU3 AZ4001VA01 00000613708BU7 AZ4013VA01 00000619361BU9 AZ1003VA01 00000620211BU3 AZ1003VA02 00000008C20253 BY4069VA01…
Every code shown here, 1,999 characters
Mfg Lot or Serial # System ID 00000466434WK8 617340LC 00000495821WK1 916734XR 0000HXNN000113 714229INNOVA 00000582921BU3 AZ4001VA01 00000613708BU7 AZ4013VA01 00000619361BU9 AZ1003VA01 00000620211BU3 AZ1003VA02 00000008C20253 BY4069VA01 0000010BC20022 BY4033VA01 0000010BC20031 BY4020VA02 00000397642BU0 BY4026VA01 00000544493BU0 BY4001VA03 00000581696BU2 BY4002VA03 00000426512BU0 BG4549VA01 00000583121BU9 BG4009VA01 00000588252BU7 BG4621VA01 00000609/70813 BG4604VA01 00000619184BU5 BG4639RX01 00000334659BU0 082406060001 00000334724BU2 082416040002 00000446999BU5 082416200006 00000006556GP5 CS1019VA01 00000549712BU8 CS1006VA04 00000549715BU1 600002VA01 00000581737BU4 CS1006VA05 0000L397H00008 CS1081RX02 000DTCE3650705 CS1021RX02 00000434952BU8 EG1003VA01 00000466657BU4 EG1235VA01 00000535385WK9 EG1102VA01 00000560477BU2 EG1741VA01 00000456800BU2 FI1015VA01 00000464655BU0 FI1064VA01 00000524177BU3 FI1017VA02 00000537029BU1 FI1017VA03 00000549714BU4 FI1025VA01 00000576357BU8 FI1314VA02 00000593473BU2 FI1126VA02 00000600318BU0 FI1023VA03 00000000001585 M86323601 00000000LS8-C1 R4211476 00000006443GP6 M4196634 00000011C2A003 A4185526 0000008C2M0006 M9162723 0000009C2M0054 M4198062 00000403124BU1 A4213138 00000420032BU5 M2030707 00000428406BU3 S4160056 00000467451BU1 M2844529 00000477885BU8 M4163030 00000509548BU4 X1347902 00000516767BU1 B1650215 00000530416BU7 M4496941 00000534726BU5 M4183841 00000577527BU5 M4202928 00000581570BU9 A4199383 00000583669BU7 M2812105 00000585910BU3 M4161021 00000589023BU1 A4498251 00000589025BU6 A4498248 00000590863BU7 M1327508 00000592451BU9 X76305707 00000600858BU5 M4212443 00000605184BU1 M4169342 00000609125BU0 A9190167 00000614537BU9 M4040085 00000614683BU1 M4152252 00000615923BU0 M1524103 00000624849BU6 M40330122 00000628834BU4 M5484994 00000629344BU3 X1347901 00000017539YC8 M199701601 00000129709BT2 M4176111 0000011C2M0011 HC0220XR10 00000450631BU7 HC5533XR08 00000593057BU3 HC3260XR04 00000611304BU7 PC3006XR03 00000618174BU7 HC5687XR09…
FDA’s list runs to 20,439 characters. The first part is shown; the rest is on FDA’s record.
Copied exactly as FDA lists them: lot and serial numbers, dates and other codes on the product or its label.
Where did it go?
FDA’s words for the “general area of initial distribution”: where the firm first shipped it.
Worldwide Distribution - US Distribution to the states of : CA and MA., and to the countries of : SPAIN, INDIA, JAPAN, AZERBAIJAN, BULGARIA, BELARUS, SWITZERLAND, CZECH REPUBLIC, GERMANY, EGYPT, FINLAND, FRANCE, UNITED KINGDOM, GUYANA, IRELAND, ISRAEL, ITALY, NIGERIA and NORWAY.
The states and territories these words name
- California
- Massachusetts
The words say it went outside the United States too.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Is it still going on?
Terminated, in FDA’s file.
“FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.”
openFDA, on “Terminated”, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
- The firm began the recall on Mar 9, 2015.
- FDA classified it on Apr 13, 2015.
- FDA’s Enforcement Report published it on Apr 22, 2015.
- FDA terminated it on Dec 21, 2015.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- GE Healthcare, of Waukesha, WI.
- Who began it, in FDA’s words: Voluntary: Firm initiated.
- How the firm first told its customers: Letter.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
What this record can’t tell you
- Whether your own one is affected: compare the codes, dates and numbers above with yours. When unsure, ask the firm or the store.
- Where it went after the firm’s first shipments. FDA’s words cover the firm’s initial distribution, and, in FDA’s words, “subsequent distribution by the consignees to other parties may not be included.”
- How many have been returned, corrected or destroyed: FDA’s report doesn’t say.
- Whether anyone was hurt or fell ill: the report doesn’t say.
- How current it is: openFDA publishes FDA’s Enforcement Report weekly, after FDA does, and a firm can announce a recall weeks before it appears there. openFDA’s own caution: “This data should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall.”
- FDA’s list of codes runs to 20,439 characters; the first part is shown here, and the rest is on FDA’s record.
- A product with no recall here isn’t safe by that: FDA’s report lists the recalls FDA classified, and when.
Hearth Record wrote these lines; the quotations are FDA’s.
Sources
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U.S. Food and Drug Administration, Device recall enforcement reports.
Released Oct 14, 2026 and checked Oct 20, 2026. Updated weekly. Public domain (CC0 1.0, openFDA). FDA asks that nothing suggest it endorses this site.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.” Copied on Oct 20, 2026.